Ethics and Regulatory Affairs Coordinator

7 months ago

Vancouver, Canada Black Tusk Research Group Full time

**REPORTS TO**

The Ethics and Regulatory Coordinator will report to the Ethics and Regulatory Research Manager.

**COMPANY OVERVIEW**

Black Tusk Research Group is a Site Management Organization (SMO) located in downtown Vancouver that specializes in operating clinical research for hospital-based investigators. This ranges from carrying out specific duties of the project including design, start-up, budgeting, financial reporting, recruitment, data collection, and study close out, to project managing from start to finish. Professional integrity and patient centered care are among our core values. We provide efficient and optimal regulatory, administrative, and project management support for clinical investigators within the Respiratory Division, Healthy Heart Clinic, Critical Care (Intensive Care unit), Pathology and the UBC Centre for Heart Lung Innovation at St. Paul’s Hospital. Our group manages both academic-grant funded and pharmaceutical/biotech funded studies, involving drugs and devices ranging across many disciplines: respiratory diseases including Chronic Obstructive Pulmonary Disease (COPD) (bronchitis and emphysema), asthma, idiopathic pulmonary fibrosis (IPF), cystic fibrosis (CF), as well as cardiovascular disease research, acute illnesses such as sepsis and pneumonia, COVID-19 and many others. This support runs the full gamut from trial initiation through study close-out.

Find out more at:
At Black Tusk Research Group we pride ourselves in career mobility, growth and development. We focus on culture, collaboration and innovation believing that with trust, mentorship and advocacy from leadership, every employee has the ability to quickly advance careers. Regardless of your position at BTRG, you’re encouraged to think big, voice your opinions, push your colleagues to excel and share your ideas with the team - meaning you have the opportunity to grow both yourself and the company. Our leaders teach best practices with early on-site training, open communication styles, regular feedback, and motivate employees to continuously learn and pursue goals.

We are looking for passionate individuals who are dedicated to advancing healthcare, and who want to be part of a dynamic industry. BTRG is searching for employees who are eager to develop with us over the next few years; the growth mindset focuses on internal career mobility and we offer all employees equal opportunities to advance in the company.

**JOB SUMMARY**:
**This role will be perfect for you if**:

- You have strong organizational and coordination skills.
- You have strong communication skills.
- You want to work in a collaborative team where your ideas are heard and valued.
- You are a story teller who has a passion for pushing the envelope.

**RESPONSIBILITIES AND DUTIES**
- Prepares, manages, and maintains ethics submissions to Research Ethics Boards.
- Acts as a primary point of contact for sponsors, principal investigators and ethics committee.
- Prepares, manages and maintains regulatory documents for each clinical trial they are tasked too.
- Writes, and reviews patient informed consent forms and patient forward documents.
- Performs regulatory review of essential documents as part of the maintenance of the study regulatory binder (Site Investigator Binders).
- Ensures submission and renewal timelines are met.
- Will participate in study specific tasks as delegated by management.
- Liaise with research teams, clinic staff and other stakeholders by coordinating meetings and preparing and distributing reports on progress
- May act as back up to Ethics and Regulatory Specialist and Research Manager.

**QUALIFICATIONS**
- Bachelor’s degree or higher in relevant discipline (Science or Arts preferred)
- 1-2 years of experience working in a fast paced environment
- Customer service experience or experience working in large group environments with various opinions and timelines.
- Research experience, is an asset.
- Ethics and Regulatory experience, is an asset.

**SKILLS**
- Excellent computer skills (word processing; excel).
- Knowledge of Clinical Research, ICH/GCP Guidelines and applicable Health Canada Guidelines is an asset
- Ability to organize own work, prioritize different tasks and work under timelines.
- Detail orientated and attention to accuracy of work
- Versatile and comfortable in a multitasking environment
- Quick learner
- Respect and adhere to established timelines, expectations, priorities and objectives
- Demonstrate ability to manage workload with existing resources, maximizing process efficiency.
- Striving to make process improvements and contributing to overall growth of company

**EQUAL EMPLOYMENT OPPORTUNITY**:
BTRG aims to ensure that when employment decisions are made, they are based on merit, not on irrelevant attributes or characteristics that an individual may possess.

Starting wage is set at $20/hr
- **BTRG strives to protect the health and well-being of our employees, patients and community. As per Pu

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